A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid Tumors
Primary Objective: To evaluate the objective response rate of nivolumab monotherapy or nivolumab combined with ipilimumab in patients with advanced or metastatic tumors. Secondary Objective: to assess the safety of nivolumab monotherapy or nivolumab combined with ipilimumab in patients with advanced or metastatic tumors.
Patients must have advanced or metastatic disease of the following cancers: - triple negative breast cancer - gastric cancer - pancreas cancer - small cell lung cancer. Patients must have measurable disease. Adequate bone marrow functioning. Must not have any prior history of cancer except for some skin cancers. Must not have active or known autoimmune diseases. Must not need systemic steroids. Must not have had chemotherapy, radiation therapy, or biologics for cancer within 28 days of study enrollment. Must not of a history or test positive for Hepatitis B, Hepatitis C, or HIV. Must not need continuous supplemental oxygen. Must hot have a history of allergic reactions to any monoclonal antibody. Must not be involuntarliy incarcerated. Must not be pregnant or breast feeding.
Patients will be randomized to either: Arm N - which is nivolumab given IV every 2 weeks until disease progression; OR Arm N-I - which is nivolumab and ipilimumab given IV every 3 weeks for 4 doses, then on Weeks 13 +, nivolumab every 2 weeks until disease progression.
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